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Recruiting NCT07298421

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

Phase III Interventional Moderately to Severely Active Crohns Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Afimkibart.
Who it may be relevant to
Registry conditions: Moderately to Severely Active Crohns Disease. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Taiwan, Thailand, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease

Overview

This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Interventions

  • Drug Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Primary outcome measures

  • Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI) [Time frame: At Week 52]
  • Percentage of Participants With Endoscopic Response [Time frame: At Week 52]
Secondary outcome measures (12)
  • Percentage of Participants With Clinical Remission [Time frame: At Week 12 and Week 52]
  • Percentage of Participants With Clinical Response [Time frame: At Week 12 and Week 52]
  • Percentage of Participants With CDAI Remission [Time frame: At Week 12 and Week 52]
  • Change From Baseline in Fecal Calprotectin [Time frame: Baseline, Week 12 and Week 52]
  • Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score [Time frame: Baseline, Week 12 and Week 52]
  • Percentage of Participants With Endoscopic Remission [Time frame: At Week 52]
  • Percentage of Participants With Corticosteroid-Free Clinical Remission [Time frame: At Week 52]
  • Percentage of Participants with Maintenance of Remission [Time frame: At Week 12 and Week 52]
  • Percentage of Participants With Histologic Improvement [Time frame: At Week 52]
  • Percentage of Participants With Ulcer-Free Endoscopy [Time frame: At Week 52]
  • Incidence and Severity of Adverse Events (AEs) [Time frame: Up to Approximately 5.5 Years]
  • Serum Concentration of Afimkibart [Time frame: Up to Approximately 5.5 Years]

Eligibility criteria

Inclusion criteria

  • Body weight >= 10 kilogram (kg)
  • Active CD confirmed by endoscopy (ileocolonoscopy)
  • Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score >= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) >=6 (or >=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
  • Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)

Exclusion criteria

  • Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
  • History of >= 3 bowel resections: > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
  • Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
  • Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  • Presence of abdominal or perianal abscess
  • Current diagnosis or suspicion of primary sclerosing cholangitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Thailand · 3 centers
  • Chulalongkorn University — Bangkok
  • Siriraj Hospital — Bangkok
  • Ramathibodi Hospital — Bangkok
Australia · 2 centers
  • Royal Children's Hospital — Parkville
  • Perth Children's Hospital — Nedlands
Taiwan · 1 center
  • National Taiwan University Hospital — Taipei
United Kingdom · 1 center
  • Sheffield Childrens Hospital — Sheffield

Identifiers

NCT: NCT07298421 · CP45906 · 2025-523318-96-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗